Clear Acne Spot Treatment

Manufacturer
Kamedis | Biogenesis Inc.
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:08:29

Label at a glance#

ProductClear Acne Spot Treatment
Active ingredientSALICYLIC ACID
Label structure3 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid unnecessary sun exposure and use sunscreen
  • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water
  • using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication at a time should be used, unless otherwise directed by a doctor

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if irritation persists

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • cleanse the skin thoroughly before applying medication
  • cover the entire affected area with a thin layer 1 to 3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • for children under 10 years of age and under, consult your physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, amur cork tree (Phellodendron amurense) bark extract, baikal skullcap (Scutellaria baicalensis) root extract, benzyl alcohol, capryloyl glycine, Chinese rhubarb (Rheum palmatum) root extract, chlorphenesin, chrysanthemum (Chrysanthemum indicum) flower extract, cinnamon (Cinnamomum zeylanicum) bark extract, common purslane (Portulaca oleracea) extract, fragrance, glycerin, great burnet (Sanguisorba officinalis) root extract, hexylene glycol, Norway spruce (Picea abis) extract, propanediol, sarcosine, SD Alcohol 40-C, sodium phytate, tromethamine, water, xanthan gum

Questions or Comments?

OTC - QUESTIONS SECTION

1-855-626-6606

SPL UNCLASSIFIED SECTION

Made in USA
(US and non-US ingredients)
Manufactured for Kamedis
Paterson, NJ 07503
1-855-626-6606

www.kamedisUSA.com

Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50718-0032-12024-02-12C16284748780-11030e365-6eee-111a-e063-dadaa90a10e2Clear Acne Spot Treatment
50718-0032-12024-01-30C16284748780-11030e365-6eee-111a-e063-dadaa90a10e2Clear Acne Spot Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0032-1Clear Acne Spot Treatment1 in 1 CARTONLIQUID15
50718-0032-1Clear Acne Spot Treatment22 mL in 1 BOTTLELIQUID225

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0032CLEAR ACNE SPOT TREATMENT (ACNE SPOT TREATMENT) LIQUID [KAMEDIS]5Current NDC, Legacy NDC, 2 package rows20240214_00764a10-f1fe-45f5-89b4-9e891a221004.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50718-003250718-0032-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Acne Spot TreatmentACNE SPOT TREATMENTKamedis00764a10-f1fe-45f5-89b4-9e891a2210042024-02-07WarningsExact identifier
ndc (package): 50718-0032-1
ndc (product): 50718-0032
ndc11 (package): 50718003201
spl id: d8bfce91-7eeb-4696-ae5f-b4fa7514f928
spl set id: 00764a10-f1fe-45f5-89b4-9e891a221004

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.